Atrial FibrillationCYKOWARNCT01042067
Safer Warfarin Treatment
An observational study of Atrial Fibrillation and Venous Thrombosis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism
- What is being tested?
- Blood specimens (whole blood, serum, plasma)
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. About 200 patients will be included.
Who may be able to join
- Caucasian
- >18 years of age
- included in the study at the onset of warfarin treatment
- target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
- standard indications for warfarin treatment
Who cannot join
- Non-caucasian
- Clinical significant liver affection
- Heart failure, NYHA class III-IV
- Non-compliant - not able to accomplish protocol demands
- Not able to give informed consent
- Long-term antibiotic therapy
- Malabsorption conditions and inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.
- Being tested
- Blood specimens (whole blood, serum, plasma)
- Keywords
- warfarin, genotyping, vitamin K, dosing, adverse events, initial phase of treatment, algorithm
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimens (whole blood, serum, plasma)Other
The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin treatment group | Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. Receives: Other: Blood specimens (whole blood, serum, plasma) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
Why it stopped: Enrolling participants has halted due to lack of investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Medicines Agency, South-Eastern Norway Regional Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042067
- Sponsor's protocol ID
- 2006-001895-18
- Acronym
- CYKOWAR
- Status last verified
- Apr 2011
- First submitted
- 4 Jan 2010
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment
- ClinicalTrials.gov ID
- NCT01042067
- Acronym / sponsor ID
- CYKOWAR / 2006-001895-18
- Keywords
- warfarin, genotyping, vitamin K, dosing, adverse events, initial phase of treatment, algorithm
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Enrolling participants has halted due to lack of investigator.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Medicines Agency, South-Eastern Norway Regional Health Authority
- Study start
- Jan 2010
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfarin treatment group | – | Other: Blood specimens (whole blood, serum, plasma)Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. About 200 patients will be included.
Key inclusion criteria (5 listed)
- Caucasian
- >18 years of age
- included in the study at the onset of warfarin treatment
- target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
- standard indications for warfarin treatment
Key exclusion criteria (7 listed)
- Non-caucasian
- Clinical significant liver affection
- Heart failure, NYHA class III-IV
- Non-compliant - not able to accomplish protocol demands
- Not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood specimens (whole blood, serum, plasma)The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens. | Other | Warfarin treatment group |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Venous Thrombosis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2011.